# Skills tagged "ISO 13485"

3 skills with this tag.

URL: https://rakenne.app/skill-tags/iso-13485/index.md

- [CAPA Report](https://rakenne.app/skills/capa-report/index.md) — Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485).
- [Design Dossier Elaborator](https://rakenne.app/skills/design-dossier-elaborator/index.md) — Guided elaboration of design dossier, technical file, or device master record sections for medical devices: device classification, risk summary (ISO 14971:2019), essential principles (GSPR), …
- [QMS CAPA Tracker](https://rakenne.app/skills/qms-capa-tracker/index.md) — Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces …

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